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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
| Boehringer Ingelheim | INDUSTRY |
| Eli Lilly and Company | INDUSTRY |
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IRIS-CKD is an implementation study to improve guideline-recommended screening of chronic kidney disease (CKD) in individuals with type 2 diabetes (T2D) in the United States.
IRIS-CKD Screening Program: will focus on CKD screening in T2D. We will identify patients with T2D that have not received appropriate screening for CKD within the last 15 months and randomize patients to receive either a home kit to complete CKD screening ("home kit") versus a standard laboratory order ("laboratory order"). The primary objective is to evaluate whether delivery of home testing kits versus standard laboratory testing influences the degree to which patients receive guideline-recommended CKD screening. Patients will complete approximately 3 months of follow-up.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (IRIS-CKD Screening Program): Home Kit | Active Comparator | Home Kit: a kit delivered to participants home with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline. |
|
| (IRIS-CKD Screening Program): Standard Lab Testing | Active Comparator | Standard Laboratory Testing: a traditional order will be placed into the Electronic Health Record (EHR) for eGFR and/or UACR testing, depending on which lab(s) are missing at baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| (IRIS-CKD Screening Program): Home Kit | Other | All participants approached for enrollment in Program 1 will receive National Kidney Foundational educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab(s) results. Home Test Kit: a kit delivered to participants homes with instructions to complete eGFR (fingerstick) and/or UACR (urine sample) testing, depending on which lab(s) are missing at baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| CKD Screening Lab Opportunity Score | Opportunity score of completion of missing guideline-recommended screening for CKD (eGFR and/or UACR) at 3 months. The opportunity score will be calculated as the ratio of the number of missing labs measured by month 3 divided by the number of missing labs at baseline. | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| CKD Screening Lab Opportunity Score by Subgroup | Opportunity score across subgroups by missing baseline screening labs: UACR only, eGFR only, or both. | 3 months |
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Screening Program-
Inclusion Criteria:
Exclusion Criteria:
• Chronic kidney disease (CKD) diagnosis
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gretchen Sanders, MSN | Contact | 919 6687829 | gretchen.sanders@duke.edu | |
| Monica Leyva, MS | Contact | monica.leyva@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Neha Pagidipati, MD | Duke University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Recruiting | Birmingham | Alabama | 35233 | United States |
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(IRIS-CKD Screening Program) is a randomized trial of delivery of a home testing kit for eGFR and/or UACR versus a standard laboratory order to increase rates of CKD screening in people who have lapsed beyond the recommended screening interval.
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| (IRIS-CKD Screening Program): Standard Lab Order | Other | ll participants approached for enrollment in Program 1 will receive National Kidney Foundation educational materials related to CKD screening in type 2 diabetes and study information. All enrolled participants will receive a message regarding study lab |
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| Orlando Health | Recruiting | St. Petersburg | Florida | 33701 | United States |
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| University of Michigan | Recruiting | Ann Arbor | Michigan | 48109 | United States |
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| Essentia Health | Recruiting | Duluth | Minnesota | 55805 | United States |
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| Duke University | Recruiting | Durham | North Carolina | 27707 | United States |
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| Houston Methodist | Recruiting | Houston | North Carolina | 77030 | United States |
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| Baylor Scott & White | Recruiting | Temple | Texas | 76508 | United States |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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